The Impact of a Remotely-Delivered Yoga Intervention on Cognitive Function in Breast Cancer Survivors: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Enrolment rate
研究概览
简要总结
The purpose of this pilot study is to assess the feasibility of a remotely-delivered yoga intervention for breast cancer survivors.
详细描述
Although up to 75% of breast cancer survivors (BCS) experience cancer-related cognitive impairment (CRCI), there are no proven treatments beyond symptom management. Exercise and yoga interventions for cancer survivors have been shown to be effective in improving other treatment-related side effects such as fatigue, quality of life (QoL), and psychological distress, but there remain several gaps in the exercise oncology literature regarding the optimal type and dose of exercise needed to mitigate CRCI. Specifically, no studies have evaluated the impact of yoga on CRCI using both self-report and objective cognitive measures. Further, no studies have evaluated the impact of a remotely-delivered yoga intervention on CRCI in breast cancer survivors.
Using a mixed-methods approach, this study will will begin to fill these gaps by evaluating the feasibility of a remotely-delivery yoga intervention on cancer-related cognitive impairment (CRCI), fatigue, and exercise levels in individuals diagnosed with breast cancer. The primary objective of this study is to assess the feasibility of a remotely-delivered yoga intervention for breast cancer survivors. This study will inform future randomized controlled trials (RCTs) examining the impact of remotely-delivered yoga interventions, with the eventual goal of providing greater access to exercise programming for symptom management for breast cancer patients and survivors.
All aspects of the study, including the assessments and the yoga intervention will take place remotely through videoconferencing. Feasibility measures, including enrolment, adherence, and attrition rates, as well as adverse events and participant satisfaction, will be tracked and assessed throughout the intervention. Objectively-assessed cognitive function will be measured using the National Institutes of Health (NIH) Virtual Toolbox Cognitive Battery and the online PsyToolkit Task Switching Test. Self-reported cognitive function will be assessed using the Functional Assessment of Cancer Therapy(FACT)-Cognitive questionnaire. Self-reported fatigue will be assessed using the Revised-Piper Fatigue Scale (PFS). Self-reported exercise will be assessed using a modified version of the Godin Leisure Time Exercise questionnaire (GLTEQ). These assessments will be taken at baseline and post-intervention. Participants will be asked to participate in the yoga intervention for 8 weeks. The yoga intervention will consist of two 60-minute yoga classes each week, which will be taught by a certified yoga instructor. Following the intervention, a sub-sample of participants will be will be purposefully selected and asked to participate in semi-structured qualitative interviews to understand their experiences with the intervention and study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
N/A - single-arm study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •primary diagnosis of Stage I-IIIa breast cancer
- •completed primary treatment(s)
- •proficient in written and spoken English
- •access to the Internet and a computer with videoconferencing capabilities
排除标准
- •colour-blind since the objective cognitive tests require participants to distinguish between colours
- •regular yoga practice defined as ≥2 times/week
- •major cognitive disorder(s) or impairment(s) (score ≤21 on the Telephone Interview of Cognitive Status)
结局指标
主要结局
Enrolment rate
时间窗: From beginning to end of recruitment period, up to 6 months.
Participant enrolment rate will be one measure of feasibility. This will be calculated as the number of participants who enrol in the intervention, divided by the total number of participants assessed for study eligibility.
Adverse events
时间窗: From beginning to end of intervention period, up to 6 months.
Adverse events will be one measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury that occurs during the yoga classes.
Burden and satisfaction
时间窗: 8 weeks post-baseline
Burden and satisfaction scores will be one measure of feasibility. This will be assessed using a researcher-generated 15-item questionnaire that asks participants about their experience with the intervention and assessments. Participants will rate items using a 5-point Likert scale (1 = 'strongly disagree', 5 = 'strongly agree').
Adherence rate
时间窗: From beginning to end of intervention period, up to 6 months.
Adherence rate, or participants' adherence to the intervention, will be one measure of feasibility. This will be calculated as the number of classes participants attend, divided by the number of classes participants are expected to attend throughout the intervention.
Attrition rate
时间窗: From beginning to end of intervention period, up to 6 months.
Attrition rate, or participant drop-out, will be one measure of feasibility. This will be calculated as the number of participants who do not complete the intervention, divided by the number of participants enrolled at the post-intervention mark.
次要结局
- Self-reported cognitive function(Baseline to 8 weeks post-baseline)
- Objectively-assessed cognitive function(Baseline to 8 weeks post-baseline)
- Self-reported fatigue(Baseline to 8 weeks post-baseline)
- Self-reported exercise(Baseline to 8 weeks post-baseline)
- Semi-structured qualitative interviews(8 weeks post-baseline)
研究者
Linda Trinh
Professor and Lab Director
University of Toronto